CLASS II Drug recall · Reported 15 Jul 2020 · FDA Enforcement Report
Cetrotide (cetrorelix acetate for Injection) 0.25 mg recalled
EMD Serono is recalling Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutaneous use only, distributed nationwide in the US. The recall was initiated on 29 Jun 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1379-2020
- FDA event ID
- 85938
- Recalling firm
- EMD Serono, Rockland, MA
- Brand
- Cetrotide
- Manufacturer
- EMD Serono, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jun 2020
- FDA classified
- 8 Jul 2020
- Reported
- 15 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Injectable & IV Drugs
Timeline
| 29 Jun 2020 | Recall initiated by company | |
| 8 Jul 2020 | Classified by FDA | +9 days |
| 15 Jul 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutaneous use only, Rx Only, Manufactured for: EMD Serono, Inc., Rockland, MD 02370, NDC: 44087-1225-1
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.
Which lots are affected?
Lot # 8J025A; 8J025B, Exp 09/30/2020
Where was it sold?
Nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from EMD Serono
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | ClomiPHENE Citrate Tablets, USP, 50 mg (2 of each) recalled | EMD Serono | Potency & Assay | Nationwide |
Other Cetrorelix recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cetrorelix Acetate for Injection , 0.25 mg per vial, Single-Dose Kit recalled | Meitheal Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Cetrorelix Acetate for Injection, 0.25 mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |